Requirements of ISO 9001-2015

→ Requirements of ISO 9001:2015 are structured in different 10 main clauses.
→ As per ISO 9001:2015, an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.


Clause Wise Requirements of ISO 9001:2015 Certification

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. The context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement
Clause Wise Requirements of ISO 9001-2015 Certification

Clause 01 Scope:

→  All the requirements of ISO 9001:2015 are intended to be applicable to any organization, Regardless of its type or size or the products and services it provides.


Clause 02) Normative Reference:

→ For Normative Reference: Refer the ISO 9000:2015, Quality Management Systems – Fundamentals and Vocabulary.


Clause 03) Terms and Definition:

→ For Terms & Definitions: Refer the ISO 9000: 2015, Quality Management Systems – Fundamentals and Vocabulary.




Clause 04) Context of the organization - Requirements of ISO 9001:2015:

Clause 04 Context of the organization

4.1. Understanding the Organization and its context

→ The context of the organization is a combination of internal and external issues.


4.2. Understanding the Needs and expectations of interested parties

→ As per this clause we have to determine the interested parties that are relevant to the Quality Management System.
→ The requirement of these interested parties that are relevant to the QMS.


4.3. Determining the Scope of the quality management system:

→ As per this clause, we have to consider the external and internal issues and the requirements of the relevant interested parties.


4.4. Quality Management system and its processes

→ To establish, implement, maintain and continually improve a Quality Management System.


Clause 05) Leadership

Clause 05 Leadership

5.1 Leadership & Commitment

→ Top management shall demonstrate leadership and commitment with respect to the QMS.


5.2 Policy

→ Establishing the Quality Policy: Top management shall establish, implement and maintain a Quality Policy.
→ It is appropriate to the purpose and contexts of the org. and supports its strategic direction.
→ Quality Policy is Provide a framework for setting quality objectives and it includes a commitment to continual improvement of the QMS.


5.3 Organizational Roles, Responsibilities and Authorities

→ Top management shall ensure that the responsibilities and authorities for relevant Role:
→ Ensuring that the quality management system conforms to the requirements of ISO 9001:2015.
→ Ensuring that the processes are delivering their intended outputs.
→ Reporting on the performance of the quality management system (as per ISO 9001:2015) and on opportunities for improvement in particular to top management.
→ Ensuring the promotion of customer focus.



Clause 06) Planning - Requirements of ISO 9001:2015:

Clause 06 Planning

6.1 Actions to Address risks & Opportunities

→ At the time of Planning for the QMS, we have to determine the
→ As per the Risk-Based Thinking in ISO 9001-2015, Risks & Opportunities that need to be addressed to :
→ Give assurance that the QMS can achieve its intended results, Enhance desirable effects.
→ Prevent or reduce undesirable effects Achieve improvement.


6.2 Quality Objectives & Planning to Achieve Them

→ Establishment of quality objectives :
➨ The Quality Objective must include the below things:
     ⇢ Be consistent with the quality policy
     ⇢ Be measurable
     ⇢ also, be relevant to the conformity of products and services and enhancement of customer satisfaction
     ⇢ Be Communicated
     ⇢ Be updated as appropriate

➨ When planning how to achieve its quality objectives, we have to determine:
     ⇢ What will be done
     ⇢ What resources will be required
     ⇢ Who will be responsible
     ⇢ When it will be completed
     ⇢ How the results will be evaluated


6.3 Planning of Changes

→ Determines the need for changes to the QMS and the changes must be carried out in the planned manner and it includes below things,
     ⇢ The purpose of the changes and their potential consequences
     ⇢ The availability of resources
     ⇢ The allocation or reallocation of responsibilities and authorities

Clause 07) Support

Clause 07 Support

7.1. Resources

→ The org. shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system
     ⇢ People
     ⇢ The infrastructure of a building,
     ⇢ Machine, equipment,
     ⇢ Transportation,
     ⇢ IT etc...
     ⇢ Suitable Environment for the operation of processes

→ Measurement Tractability :
➨ The measuring equipment must be:
     ⇢ Calibrated or verified,
     ⇢ Identified in order to determine their status
     ⇢ Safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.


7.2. Competence

→ Determine the necessary competence of a person(s) doing work
→ Ensure that these persons are competent on the basis of appropriate education, training, or experience
→ Retain appropriate documented information as evidence of competence.




7.3. Awareness

→ The persons doing work are aware of:
     ⇢ The quality policy
     ⇢ Relevant quality objectives
     ⇢ Their contribution to the effectiveness of the QMS, including the benefits of improved performance


7.4. Communication

→ Determine the internal and external communications relevant to the QMS, including :
     ⇢ On what it will communicate
     ⇢ When to communicate
     ⇢ With whom to communicate
     ⇢ How to communicate
     ⇢ Who communicate


7.5. Documented Information [DI]

→ The QMS must include below things.
➨ [A] Creating and updating:
→ Below things must consider at the time of creating and updating [DI],
     ⇢ Identification and description (e.g. a title, date, reference number, etc...)
     ⇢ Format (e.g. language, software version, graphics)
     ⇢ Media (e.g. paper, electronic)
     ⇢ Review and approval for suitability and adequacy

➨ [B] Control of documented information:
→ DI required by the QMS and ISO 9001:2015 shall be controlled to ensure:
     ⇢ It is available
     ⇢ suitable for use,
     ⇢ where and when it is needed

→ for the control of documented information, address the following activities :
     ⇢ Distribution, access, retrieval, and use
     ⇢ Storage and preservation, including preservation of legibility
     ⇢ Control of changes (e.g. version control)       
     ⇢ Retention and disposition



Clause 08) Operation - Requirements of ISO 9001:2015:

Clause 08 Operation

8.1. Operation Planning and Control

→ The organization shall plan, implement and control the processes.
→ Determining the requirements for the products and services
➨ Establishing criteria for :
     ⇢ The processes
     ⇢ The acceptance of products and services


8.2. Requirements for Products

→ Customer Communication :
➨ Communication with the customer must include:
     ⇢ Providing information relating to products and services
     ⇢ Handling inquiries, contracts or orders, including changes
     ⇢ Obtaining customer feedback relating to products and services, including customer complaints
     ⇢ Handling or controlling customer property

➨ The org. must ensure that
     ⇢ Any applicable statutory and regulatory requirements
     ⇢ Those considered necessary by the org.


8.3. Design and development of products and Services

→ The org. must establish, implement and maintain design and development the process that is appropriate to ensure the subsequent provision of products and services.

➨ [A] Design and development inputs:
     ⇢ Function and performance necessity
     ⇢ Statutory and regulatory necessity

➨ [B] Design and development controls
→ The org. must apply controls to the design and development process to ensure:
     ⇢ The results to be  achieved are defined
     ⇢ Verification activities – meet the input necessity
     ⇢ Validation activities – meet the necessity for the specified application
     ⇢ Any necessary actions are taken on problems determined during the reviews, or verification and validation activities
     ⇢ Documented information of these activities is retained

➨ [C] Design and development outputs
     ⇢ The org. shall ensure that the design and development outputs:
     ⇢ Meet the input necessity

➨ The org. must retain DI on:
     ⇢ Design and development changes
     ⇢ The results of reviews
     ⇢ The authorization of the changes
     ⇢ The actions are taken to prevent impact


8.4. Control of Externally Provided Processes, Products, and Services

→ The org. shall determine :
→ A process, or part of a process, is provided by an external provider as a result of a decision by the organization

➨ The organization must determine and apply criteria for:
     ⇢ Evaluation,
     ⇢ Selection,
     ⇢ Monitoring of performance and
     ⇢ Re-evaluation of external providers




8.5. Production and Service Provision

➨ [A] Control of product and service provision:
→ The availability of documented information that defines:
     ⇢ Characteristics of the products to be produced and the services to be provided
     ⇢ The results to be achieved
     ⇢ Implementation of monitoring and measurement activities
     ⇢ Use of suitable infrastructure and environment for the operation of processes
     ⇢ The implementation of release, delivery, and post-delivery activities

➨ [B] Identification and Traceability:
     ⇢ The org. shall identify outputs when it is necessary to ensure the conformity of products and services
     ⇢ Control the unique identification of the outputs when traceability is a requirement,
     ⇢ Retain the documented information necessary to enable traceability.

➨ [C] Property belonging to customer or external providers
     ⇢ The org. shall identify, verify, protect and safeguard customers’ or external providers’ property provided.
     ⇢ When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain DI on what has occurred.

➨ [D] Preservation
     ⇢ The org. must preserve the outputs during production and service provision.
➨ Preservation can include:
     ⇢ Identification,
     ⇢ Handling,
     ⇢ Contamination control,
     ⇢ Packaging storage,
     ⇢ Transmission or transportation, and
     ⇢ Protection.

➨ [E] Post-delivery activities:
→ The organization must consider:
     ⇢ Statutory and regulatory requirements
     ⇢ Nature, use and intended lifetime of its products and services
     ⇢ Customer requirements
     ⇢ Customer feedback
     ⇢ Warranty provisions

➨ [F] Control of changes:
     ⇢ Review and control of changes for production or service provision and retain DI.


8.6. The Release of Products and Services

→ Retain documented information [DI] on the release of products and services
➨ The DI must include:
     ⇢ Evidence of conformity with the acceptance criteria
     ⇢ Traceability to the person(s) authorizing the release


8.7. Control of Nonconforming outputs

→ The organization shall ensure that outputs that do not conform to its requirements are identified and controlled to prevent their unintended use or delivery
→ The organization has to take appropriate action based on the nature of the nonconformity.
➨ Also, deal with nonconforming outputs like,
     ⇢ Correction
     ⇢ Segregation, containment, return
     ⇢ Informing the customer
     ⇢ Obtaining authorization for acceptance under concession
     ⇢ Conformity to the requirements must be verified when nonconforming outputs are corrected.

➨ The organization must have to retain documented information that
     ⇢ Describes the nonconformity
     ⇢ Mentions the actions taken
     ⇢ Describe any concessions obtained
     ⇢ Identifies the authority deciding the action in respect of the nonconformity



Clause 09) Performance Evaluation - Requirements of ISO 9001:2015:

Clause 09 Performance Evaluation

9.1. Monitoring, Analysis, Measurement & Evaluation

➨ [A] The organization shall determine:
     ⇢ What needs to be monitored and measured
     ⇢ The methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results
     ⇢ The organization must retain appropriate documented information as evidence of the results

➨ [B] Customer satisfaction

     ⇢ The organization shall monitor customers’ perceptions of the degree to which their needs and expectation have been fulfilled

➨ [C] Analysis and Evaluation
     ⇢ The results of the analysis shall be used to evaluate :
     ⇢ Conformity of product and services
     ⇢ The degree of customer satisfaction
     ⇢ The performance and effectiveness of the QMS
     ⇢ The effectiveness of actions taken to address risks and opportunities
     ⇢ The performance of external providers


9.2. Internal Audit

→ The organization must conduct internal audits at planned intervals to provide information on whether the QMS Conforms to:
→ The organization’s requirements for its QMS
→ The requirements of ISO 9001:2015
→ Is effectively implemented and maintained
➨ The organization shall
     ⇢ Plan, establish, implement and maintain an audit program including the frequency, method, responsibilities & planning requirements.
     ⇢ Select auditors and conduct audits
     ⇢ Take appropriate correction and corrective actions without undue delay
     ⇢ Retain documented information as evidence of the implementation of the audit program and the audit results




9.3 Management Review

→ Top management shall review the organization’s QMS at planned intervals, to ensure its continuing suitability, effectiveness, and alignment with the strategic direction of the organization

➨ [A] Management Review Inputs:
     ⇢ The status of actions from previous management reviews
     ⇢ Customer satisfaction and feedback from relevant interested parties
     ⇢ Non-conformities and corrective actions
     ⇢ Audit results
     ⇢ The performance of external providers
     ⇢ Adequacy of resources
     ⇢ The effectiveness of actions taken to address risks and opportunities

➨ [B] Management Review Outputs:
     ⇢ Opportunities for improvement
     ⇢ Any need for changes to the QMS
     ⇢ Resource needs
     ⇢ Retain documented information as evidence of  the results of management reviews


Clause 10) Improvement

Clause 10 Improvement

10.1. General

→ Improving products and services to meet requirements as well as to address future needs and expectations
→ Correcting, preventing or reducing undesired effects
→ Improving the performance and effectiveness of the QMS


10.2. Non-conformity & corrective action

➨ The organization shall :
     ⇢ Take action to control and correct it
     ⇢ Deal with the consequences
     ⇢ Reviewing and analyzing the nonconformity
     ⇢ Determining the causes of the nonconformity
     ⇢ Determining if similar nonconformities exist, or could potentially occur
     ⇢ Corrective actions shall be appropriate to the effects of the nonconformities encountered
     ⇢  Retain documented information as evidence of the nature of the nonconformities and action taken, and the results of any corrective action.

10.3. Continual Improvement

→ The organization shall continually improve the Quality Management System.


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